Phil,
It looks like problem of FDA being unable to keep up with timely approval process of drugs is becoming more and more apparent.
Implementation of ideas spelled out in this excerpt:
"To improve drug evaluation, the group says the FDA needs to more frequently pursue accelerated approvals, paired with post-approval studies to evaluate drugs addressing unmet needs; it suggests the agency create a new pathway for approving drugs shown to be safe and effective for a specific subgroup of patients; and, the FDA should explore approaches for adaptive approvals, it says, a framework for iteratively expanding the market for a drug as new evidence about its risks and benefits becomes available."
are great starters in getting much improved drugs out in more timely fashion to patients in need.
http://www.burrillreport.com/article...approvals.html